MAUDE Adverse Event Report: MEDTRONIC MEXICO AVALUS ULTRA BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	400U23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during the implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a 21mm valve of the same model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Updated data: b.5: event description d.4: unique identifier (udi) #: h.6: coding.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received that reported the reason for replacement as the valve was oversized.It was further reported that avalus sizers were used for the implant, and the barrel and replica end of the sizer were used.It was further reported that the annuus was felt to be between 2 different sizes, size 21mm and 23mm.It was also reported it was preference of the physician to upsize the valve for a larger effective orifice area (eoa).The body surface area (bsa) chart was used and indicated a larger size was needed.Pledgets were also used during the implant procedure.No additional adverse patient effects were reported.

• Brand Name: AVALUS ULTRA BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22366185
• Report Number: 9612164-2025-03223
• Device Sequence Number: 12834279
• Product Code: DYE
• UDI-Device Identifier: 00763000647049
• UDI-Public: (01)00763000647049(17)280314(21)K085154(20)01
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400U23
• Device Catalogue Number: 400U23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 03/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female